Glaucoma Medication AdherenceNCT02097979
The Impact of a Brief Educational Intervention on Glaucoma Adherence
A study testing Glaucoma Educational Intervention in people with Glaucoma Medication Adherence, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
OBJECTIVE Our objective was to determine whether two group educational sessions plus one-on-one eye drop instillation training would improve adherence to glaucoma therapy as measured by pharmacy claims data in a cohort of newly diagnosed patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma Medication Adherence
- What is being tested?
- Glaucoma Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
OBJECTIVE Our objective was to determine whether two group educational sessions plus one-on-one eye drop instillation training would improve adherence to glaucoma therapy as measured by pharmacy claims data in a cohort of newly diagnosed patients. Our hypothesis was that adherence would be improved in the intervention group and that patients would better understand their disease and how to manage it.
METHODS Study Design and Population: A randomized controlled clinical trial was conducted in newly diagnosed glaucoma patients at Maisonneuve-Rosemont Hospital in Montreal, Canada. Half of the participants were randomized to receive the intervention and half were randomized to receive a delayed intervention at the conclusion of the study. Inclusion criteria included a diagnosis of glaucoma requiring intraocular pressure lowering eye drop therapy and prescription drug insurance through the Régie de l'Assurance Maladie du Québec (RAMQ) (the Quebec Health Insurance Program) throughout the course of the study. There were three sources of data for this study: a questionnaire, the medical record, and RAMQ prescription drug claims data. Follow-up was for one year.
Read more
Recruitment and Randomization: From July, 2007 until December, 2011, a researcher approached eligible patients to determine their interest in participating in the study. Interested participants signed the informed consent form and were randomized. Participants in the intervention group were given an appointment to come back to the Hospital for the group intervention. Participants in the control group were given an appointment to receive the group intervention at the end of the study.
Intervention: Small groups of about 10 people were gathered for two 60-90 minute educational sessions on glaucoma in a classroom at Maisonneuve-Rosemont Hospital. During a break, each patient received one-on-one teaching on how to properly instill drops without touching the eye or using unnecessary drops.
Questionnaire and Assessment of Eye Drop Technique: A single questionnaire was given at the end of the study to all participants. The intervention group completed the questionnaire after the intervention while the control group completed the questionnaire before the intervention. Questions were included on demographics, systemic comorbidities, ocular medications, eye drop practices and difficulties, and glaucoma knowledge.
The instructor rated the ability of the participant to put eye drops in the eye taking into account the number of drops that were used and whether contact with the lid or conjunctiva occurred (good, fair, bad).
We created a composite score on the perception of the importance of glaucoma eye drop therapy using the following four questions: 1) do you think glaucoma is a serious disease, 2) do you believe that your treatment will be effective, 3) do you think your drops can lower the pressure in your eyes, 4) do you think your drops can help to preserve vision. Answers of no or do not know were given 0 points and answers of yes were given 1 point. Scores were summed and the composite score ranged from 0 to 4.
Medical Chart Review: At the end of the follow-up period, information was obtained on: the prescribed eye drop therapy for each patient per eye, whether the patient had undergone glaucoma filtering surgery, whether the patient had died or was no longer being followed, the most recent visual field mean deviation in the better eye using the Humphrey Visual Field Analyzer 24-2 SITA Standard Program.
Pharmaceutical Claims and Calculation of Medication Possession Ratio: The Medication Possession Ratio (MPR) was calculated as the sum of days of prescription supply divided by the number of days in which a prescription was required. Each person gave consent to contact the RAMQ to obtain pharmaceutical claims for all glaucoma medications. Data were collected on the date of purchase, and the name, dose, and class of the medicine. Data on the number of days of medication available per bottle were taken from the Rylander and Friedman studies with the minimum value used. For the numerator of the MPR, we calculated how many days of medication were available using RAMQ data. For the denominator of the MPR, we calculated the number of days that medication was prescribed in the medical chart. We took into account whether drops were needed for one or two eyes. If a participant was on multiple medications, we calculated a single mean MPR for all medications. We then dichotomized the MPR so that those having medication less than 75% of the days were defined as non-adherent, as we did previously in Djafari et al.
SIGNIFICANCE Adherence can be a problem in glaucoma because patients must often take daily eye drops despite not noticing any benefit to their vision and despite frequent side effects. Low cost interventions that help to improve adherence are needed.
- Conditions
- Glaucoma Medication Adherence
- Being tested
- Glaucoma Educational Intervention
- Keywords
- glaucoma, adherence, medication possession ratio, intervention
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma Educational InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Educational Intervention | Experimental | Not described Receives: Behavioral: Glaucoma Educational Intervention |
| Delayed Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Possession Ratio
Measured: 1-year post enrollment
Secondary outcomes (2)
Eye drop instillation technique
Eye drop instillation technique was measured by direct observation. This was done in the experimental group immediately after the educational session and in the control group immediately before the educational session.
Measured: At beginning or end of educational session
Perception of the importance of glaucoma eye drop therapy
Perception of the importance of glaucoma eye drop therapy was measured by questionnaire. In the experimental group this was done immediately after the educational session and in the control group this was done just before the educational session.
Measured: At beginning or end of educational session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startJul 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Ellen Freeman, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097979
- Sponsor's protocol ID
- Pfizer Canada NRA6110029
- Status last verified
- Mar 2014
- First submitted
- 13 Mar 2014
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Djafari F, Lesk MR, Harasymowycz PJ, Desjardins D, Lachaine J. Determinants of adherence to glaucoma medical therapy in a long-term patient population. J Glaucoma. 2009 Mar;18(3):238-43. doi: 10.1097/IJG.0b013e3181815421.
PubMed 19295380
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Brief Educational Intervention on Glaucoma Adherence
- ClinicalTrials.gov ID
- NCT02097979
- Acronym / sponsor ID
- Pfizer Canada NRA6110029
- Conditions
- Glaucoma Medication Adherence
- Keywords
- glaucoma, adherence, medication possession ratio, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE Our objective was to determine whether two group educational sessions plus one-on-one eye drop instillation training would improve adherence to glaucoma therapy as measured by pharmacy claims data in a cohort of newly diagnosed patients. Our hypothesis was that adherence would be improved in the intervention group and that patients would better understand their disease and how to manage it.
METHODS Study Design and Population: A randomized controlled clinical trial was conducted in newly diagnosed glaucoma patients at Maisonneuve-Rosemont Hospital in Montreal, Canada. Half of the participants were randomized to receive the intervention and half were randomized to receive a delayed intervention at the conclusion of the study. Inclusion criteria included a diagnosis of glaucoma requiring intraocular pressure lowering eye drop therapy and prescription drug insurance through the Régie de l'Assurance Maladie du Québec (RAMQ) (the Quebec Health Insurance Program) throughout the course of the study. There were three sources of data for this study: a questionnaire, the medical record, and RAMQ prescription drug claims data. Follow-up was for one year.
Recruitment and Randomization: From July, 2007 until December, 2011, a researcher approached eligible patients to determine their interest in participating in the study. Interested participants signed the informed consent form and were randomized. Participants in the intervention group were given an appointment to come back to the Hospital for the group intervention. Participants in the control group were given an appointment to receive the group intervention at the end of the study.
Intervention: Small groups of about 10 people were gathered for two 60-90 minute educational sessions on glaucoma in a classroom at Maisonneuve-Rosemont Hospital. During a break, each patient received one-on-one teaching on how to properly instill drops without touching the eye or using unnecessary drops.
Questionnaire and Assessment of Eye Drop Technique: A single questionnaire was given at the end of the study to all participants. The intervention group completed the questionnaire after the intervention while the control group completed the questionnaire before the intervention. Questions were included on demographics, systemic comorbidities, ocular medications, eye drop practices and difficulties, and glaucoma knowledge.
The instructor rated the ability of the participant to put eye drops in the eye taking into account the number of drops that were used and whether contact with the lid or conjunctiva occurred (good, fair, bad).
We created a composite score on the perception of the importance of glaucoma eye drop therapy using the following four questions: 1) do you think glaucoma is a serious disease, 2) do you believe that your treatment will be effective, 3) do you think your drops can lower the pressure in your eyes, 4) do you think your drops can help to preserve vision. Answers of no or do not know were given 0 points and answers of yes were given 1 point. Scores were summed and the composite score ranged from 0 to 4.
Medical Chart Review: At the end of the follow-up period, information was obtained on: the prescribed eye drop therapy for each patient per eye, whether the patient had undergone glaucoma filtering surgery, whether the patient had died or was no longer being followed, the most recent visual field mean deviation in the better eye using the Humphrey Visual Field Analyzer 24-2 SITA Standard Program.
Pharmaceutical Claims and Calculation of Medication Possession Ratio: The Medication Possession Ratio (MPR) was calculated as the sum of days of prescription supply divided by the number of days in which a prescription was required. Each person gave consent to contact the RAMQ to obtain pharmaceutical claims for all glaucoma medications. Data were collected on the date of purchase, and the name, dose, and class of the medicine. Data on the number of days of medication available per bottle were taken from the Rylander and Friedman studies with the minimum value used. For the numerator of the MPR, we calculated how many days of medication were available using RAMQ data. For the denominator of the MPR, we calculated the number of days that medication was prescribed in the medical chart. We took into account whether drops were needed for one or two eyes. If a participant was on multiple medications, we calculated a single mean MPR for all medications. We then dichotomized the MPR so that those having medication less than 75% of the days were defined as non-adherent, as we did previously in Djafari et al.
SIGNIFICANCE Adherence can be a problem in glaucoma because patients must often take daily eye drops despite not noticing any benefit to their vision and despite frequent side effects. Low cost interventions that help to improve adherence are needed.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Educational Intervention | Experimental | Behavioral: Glaucoma Educational Intervention |
| Delayed Intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glaucoma Educational Intervention | Behavioural | Glaucoma Educational Intervention |
Primary outcome
Medication Possession Ratio
Time frame: 1-year post enrollment
2 secondary outcomes
Eye drop instillation technique
Time frame: At beginning or end of educational session
Perception of the importance of glaucoma eye drop therapy
Time frame: At beginning or end of educational session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Background: PubMed 19295380Djafari F, Lesk MR, Harasymowycz PJ, Desjardins D, Lachaine J. Determinants of adherence to glaucoma medical therapy in a long-term patient population. J Glaucoma. 2009 Mar;18(3):238-43. doi: 10.1097/IJG.0b013e3181815421.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaucoma Educational Intervention in people with Glaucoma Medication Adherence, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Possession Ratio (time frame: 1-year post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02097979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.